Product Development: Due Diligence, Strategy & Study Management for NCE in EU
04 august 2022
Customer Understanding
Customer profile
Small European based Research and Development company intending to develop and register their first NCE targeting Non-Alcoholic Fatty Liver Disease (NAFLD) & Steatohepatitis (NASH).
This drug was not authorised anywhere in the world.
Customer Challenges
- Due to the size and nature of the company, they possessed expertise in drug development, but have very little expertise in pre-clinical and clinical regulations.
- Initial data collected had not been validated against the latest regulations for compliance.
- The client lacked experience in selecting Clinical Research Organisation (CRO) for pre-clinical & clinical studies.
- Client did not have in house pre-clinical & clinical experts to design a development plan for required studies.
- Client had limited ability to manage all the necessary studies and data analysis required for pre-clinical and clinical requirements.
PLG’s Responsibilities & Activities
Scope of work provided:
Due Diligence
- With the client’s existing data, PLG conducted a due diligence identifying possible gaps that could exist.
- PLG conducted robust literature searches using regulatory requirements and similar product types precedents to create a development plan for the product, inclusive of Good Laboratory and Good Clinical Practices (GLP & GCP).
Product Development
- PLG created the development plan and initiated contact with several CROs on behalf of the client to select the appropriate candidate to carry out the pre-clinical studies.
- Currently PLG is managing on behalf of the client the 180-day toxicology programme with upcoming studies, including 28 days of repeat dose toxicity, Safety Pharmacology, Metabolite Profiling, PK & Genotoxicity studies.
Solution provided by PLG
The client benefited from:
- A team of highly skilled and experienced pre-clinical & clinical experts to assess current data and design development plans.
- Qualification & Selection of CRO to conduct studies.
- A robust Project Management plan with allocated milestones to keep the project on track.
- In conjunction with the above SMEs, a dedicated Project Management team to assist in the collection of study data and keeping the client in constant communication for timely updates.
Added-value and customer benefits
Added-value
- Specific Subject Matter Expert resources dedicated to the client’s project.
- A cost-effective solution with centralized project management & offshore operational resources.
- KPI: 80-90% reduction in the manpower needed due to automation instead of manual processes.
PLG success factors
- Flexibility in working with the client’s preferred schedule of payment.
- PLG’s holistic understanding of the client’s “wants and needs”, while managing the client’s realistic expectations.
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